Veterinary Medicines

Nifencol 300 mg/ml solution for injection for cattle and pigs

Authorised
  • Florfenicol
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Product identification

Medicine name:
Nifencol 300 mg/ml solution for injection for cattle and pigs
Nifencol 300 mg/ml solution for injection for cattle and pigs
Active substance:
  • Florfenicol
Target species:
  • Cattle
  • Pig
Route of administration:
  • Intramuscular use
  • Subcutaneous use

Product details

Active substance and strength:
  • Florfenicol
    300.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Cattle
      • Meat and offal
        30
        day
    • Pig
      • Meat and offal
        18
        day
  • Subcutaneous use
    • Cattle
      • Meat and offal
        44
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QJ01BA90
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Ireland
Available in:
  • Ireland
Package description:
  • Polypropylene vial of 100 ml, closed with bromobutyl stopper secured with flip-off aluminium collar. Package size: Cardboard box with 1 vial of 100 ml
  • Polypropylene vial of 250 ml, closed with bromobutyl stopper secured with flip-off aluminium collar. Package size: Cardboard box with 1 vial of 250 ml

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Generic application (Article 13(1) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Vetpharma Animal Health S.L.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Mevet S.A.U.
Responsible authority:
  • Health Products Regulatory Authority
Authorisation number:
  • VPA10516/007/001
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0374/001
Concerned member states:
  • Austria
  • Belgium
  • Croatia
  • Czechia
  • France
  • Germany
  • Hungary
  • Luxembourg
  • Netherlands
  • Poland
  • Slovakia
  • Spain
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 11/02/2022
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